Drugmaker Eli Lilly says that approval of its experimental Alzheimer’s medication donanemab will be delayed beyond the end of March as the FDA plans to call a last-minute meeting of its advisers
— Drugmaker Eli Lilly says that approval of its experimental Alzheimer’s medication donanemab will be delayed beyond the end of March as the US Food and Drug Administration plans to call a last-minute meeting of its outside advisers to review the drug’s safety and efficacy.
The FDA told Lilly that it plans to call the advisory meeting to discuss the safety of donanemab, as well as the design of a key clinical trial supporting its application, called Trailblazer-Alz 2, the company said in a news release Friday. The date for the meeting hasn’t been set, Lilly said. The main safety concerns with these medicines are brain swelling and micro-hemorrhages known as amyloid-related imaging abnormalities, or ARIA. In donanemab’s Phase 3 clinical trial, 37% of participants had ARIA, including three who died.Lilly said the FDA also wanted its outside experts to weigh in on the “unique trial design” of the donanemab study, which allowed patients to stop taking the drug once the amyloid plaques were shown to be cleared from the brain.
When people with high levels of tau — who are thought to be further along in the disease — were included, the benefit compared with placebo was 22%.
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